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FDA 510(k) Application Details - K000637
Device Classification Name
Aberrometer, Ophthalmic
More FDA Info for this Device
510(K) Number
K000637
Device Name
Aberrometer, Ophthalmic
Applicant
ALCON LABORATORIES, INC.
2800 DISCOVERY DR.,
ORLANDO, FL 32826-3714 US
Other 510(k) Applications for this Company
Contact
S.K. MCGARVEY
Other 510(k) Applications for this Contact
Regulation Number
886.1760
More FDA Info for this Regulation Number
Classification Product Code
NCF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/25/2000
Decision Date
05/19/2000
Decision
SESU - SE - WITH LIMITATIONS
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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